The present invention relates to devices for separating bodily tissues and, more particularly, to devices for separating outer wall tissues from inner structure tissues to dilate nasal passages of a human nose.
Humans are often subject to interior obstructing of their nasal passages which makes breathing more difficult. Examples of such obstructing are a deviated septum typically resulting from injury to the nose, swelling of interior nose tissues due to allergic reactions, and the nasal symptoms present in those suffering with the common cold. The lower portion of a nostril, immediately interior the entrance to the nostril, is known as a vestibule. The vestibule tapers inwardly to a narrowed neck-like area called the nasal valve. Nasal passages, posterior to the nasal valve, widen again. Nasal obstructions commonly occur at the nasal valve to the point that the nasal valve may be substantially blocked. Commonly, the lateral wall (i.e., the outer wall tissues partially about the nasal passage) at the nasal valve is loose with the result that the outer wall tissues draw in during the inhalation portion of the breathing process to substantially or completely block passage of air through the nasal passage particularly if such obstruction is present.
Blockage of the nasal passage is obviously an irritation and a possible detriment to persons who experience it. In particular, sustained mouth breathing over a long period of time may cause lung irritation due to the inhalation of foreign particles that would otherwise be filtered if the breath had passed through the nose. Blockage of the nasal passage is particularly uncomfortable at night, since it is uncomfortable for many people that have a problem to breathe through their mouth while asleep. Nasal blockages can lead to sleep disturbances, sleep irregularities, or snoring or a combination thereof. In addition, a person with such a condition may wake often because that person is not easily inhaling sufficient quantities of oxygen.
Where the cause of the obstruction in the nasal passage is due to structural problems such as a deviated septum or an unusually small valve opening, and where the effect on breathing is relatively serious, a common resort is to surgically attempt to correct the malformation of the nasal passages. However, surgery is expensive and may not ultimately correct the problem. Where the cause is allergies or the common cold, another alternative often used is a medicated spray to reduce the associated swelling of tissues along the nasal passages. This treatment too often was insufficient to alleviate the problem, and there are possible detrimental effects on the tissues themselves with long-term use.
Because of these shortcomings experienced using these methods, mechanical aids termed nasal dilators have been used in attempts to open nasal passages. Such dilators have been both of the internal variety which in effect push out the sides of the nasal passages to open them, and of the external variety effectively pulling on some of those sides. The internal types, which require insertion in the nasal passages, may irritate them and result in an itching feeling. Because of the large variety of geometries encountered in human nasal passages, these nasal dilators often must be specifically designed for each particular user. External nasal dilators have either been securely adhered to the user's nose (requiring some aid to remove) but adjustable with respect to the force of the pull on the outer wall tissues, or have been removably adhered to the user's nose but unadjustable single body items which provide a force pulling on wall tissues determined by the single body structure. The former are difficult to remove and difficult to adjust to provide a proper force which yields sufficient expansion of the wall tissues without the mechanical arrangement for doing so becoming disengaged, knocked askew during ordinary use, or the like.
Single body external nasal dilators have had designs developed therefor which provide a satisfactory outwardly pulling force on tissues being dilated without discomfort, and which can also be relatively easily put in place for use as a dilator while yet being relatively easily removed. This latter feature has been accomplished in dilators using spring containing bodies with pressure sensitive adhesives, and the peel forces, which are generated by the relatively stiff spring ends along with motion of the skin under and adjacent to such dilators adhered thereto using such adhesives, has been prevented from causing the dilators to separate from the skin through a suitable geometry at the ends thereof. One possibility is to use spring members in the dilator body which are of shorter length than the length of the body in which they are contained so that centering the position of such spring members in that body leaves each of the spring member ends spaced apart from the corresponding body ends. This possibility was shown in earlier filed copending U.S. Patent Application by B. C. Johnson entitled "Nasal Dilator" having Ser. No. 08/183,916 and filed on Jan. 19, 1994 which is hereby incorporated herein by reference. In effect, the portions of the body ends past the spring members ends serve as body extensions that resist the peel forces occurring at the ends of these spring members. Unfortunately, the need to individually position spring members during the manufacturing process is expensive and subject to errors.
Alternatively, the central end portions of the dilator body at the opposite ends thereof past the spring member ends can be cut out during manufacture so that the end edges reach back to the ends of the short spring members or, more practically, the springs, rather than being short and positioned, can extend for the length of the dilator body before being cut into units with the central end portions being cut out along with the cutting into units. This will leave body side extensions without any spring member portions therein, and these side extensions will extend past the ends of the spring members after such cutting as described in earlier filed copending U.S. Patent Application by W. J. Doubek, D. E. Cohen and B. C. Johnson entitled "Nasal Dilator" having Ser. No. 08/070,554 and filed on Apr. 20, 1993 which is hereby incorporated herein by reference. However, the adhering extensions used in the geometry of the dilator ends described there to prevent that dilator from peeling away from the skin restrict the possible end shapes which might otherwise be used and, because such extensions do extend past the spring members in the dilator body, they unavoidably result in some waste of material in the manufacturing process. This situation can be eased by eliminating any central end portions being cut out and, instead, just providing relief cuts between the spring members and the side extensions portions. Such an arrangement, however, will result in a small amount of peeling of the central end portions not cut out as they were in the previous version. The resulting peeled away central end portions will be subject to catching onto objects brought into contact with, or near to, the wearer's nose, collecting dirt, becoming unsightly, causing itching, etc.
In addition, the skin under those extensions accumulates some moisture therein due to the reduced evaporation therefrom resulting from the presence of the extensions over that skin which weakens the structure thereof at such locations. At dilator removal, the forces between the dilator extensions and the skin change from being primarily peel forces to being primarily sheer forces which are much greater in magnitude due to the nature of the pressure sensitive adhesive used on the extensions, and so there is a potential for damaging the weakened skin upon the introduction of the greater magnitude of sheer forces during removal of those extensions from the skin.
On the other hand, the omission of the extensions or any relief cuts between the spring force member and the adjacent side portions of the dilator leads to the spring members reaching the extreme end edges of the dilator. The substantially constant spring force along the dilator from end edge to end edge provided by the resilient members therein, along with the relatively high stiffness of short sections of the spring back from the end edges, leads to the occurrence of peel forces due to the motion of the skin beneath the dilator during ordinary use that are sufficient in a significant number of dilator uses to cause the ends of the dilator to begin to disengage from the skin of the user therebeneath. Thus, there is a desire for a single body dilator structure that reduces waste in manufacture, allows design freedom for the ends of dilators, and reduces the risk of skin damage during separation of the dilator from the user's skin.